OBR Daily Commentary

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AMA Says Prior Authorizations Increasing, Interfering With Care Continuity

(Healthcare Dive) Mar 13, 2019 - The number of prior authorization requirements has increased in the past five years and 85% of physicians say the practice interferes with continuity of care, according to a new survey from the American Medical Association.

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William McGivney, PhD (Posted: March 14, 2019)

quotesPayer Prior Authorization: Intrusion, Disruption and Patient Harm Is it any surprise that the frequency of payer prior authorizations continues to rise? The arrogance and greed of the payer/MCO industry dominates good sense and dismisses or, more to the point, disses patient well-being. Oftentimes, prior authorization programs are developed and marketed alone or in combination with other intrusive activities to the employer customers. The sale of such programs generates revenue that hits the bottom line of these payers/MCOs. Did you ever wonder why the Claims Cost totals are generally about 85-88% of the reported Medical Costs of a payer. As the oft-quoted Yogi Berra would say: “You could look it up”; although annual Claims costs are not always easily found. A significant percentage of the Medical Costs minus Claims paid costs proceed to hit the revenue and profit bottom lines of payers/MCOs. In the drug/biologic world of Oncology, about 1% of prescriptions are ultimately denied. The disruption, delay and harm caused by intrusive prior authorization seems of little consequence to payors/MCOs as they forage and, more accurately, ravage the managed care landscape. I could go on and on but my soon-to-be-released book, On the Road to KICK-ASS HealthCare™ will tell the behind-the-scenes story. One vignette sums up the absurdity of what we tolerate. An endowed professor at a prestigious Medical Center and longtime NCCN Panel Chair tells the story of what we will generously call a “Peer to Peer” discussion on a prior auth disagreement. The internationally respected medical oncologist found out that she/he was speaking with a cardiology nurse from the payer who proceeded to lecture her/him on what the relevant NCCN Guideline recommended. After exhibiting patience, reserve, and restraint, the good doctor informed the payer cardiology nurse that she/he, indeed, was the chairperson of the relevant panel and had been for many years. She/he then educated the cardiology nurse on what the particular NCCN Guideline really said. This story might be amusing, if not for the fact that behind the enormous waste of time and money was a patient who thought that he/she had traveled the 300 miles to have this world’s leading oncologist determine what was best for her/him; not some script-bound cardiology nurse in some cubicle otherwise removed from the cancer care delivery system. quotes

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U.S. Proposes Medicare Coverage For CAR-T Cancer Therapies

(Reuters) Feb 15, 2019 - The U.S. Centers for Medicare & Medicaid Services (CMS) on Friday proposed Medicare coverage of approved CAR-T cell therapies that use the patient’s immune system to fight cancer. The proposal would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment, CMS said. The evidence from these studies and registries would help the agency identify the patients that benefit from CAR-T cell therapies.

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William McGivney, PhD (Posted: February 20, 2019)

quotesCED for CAR-T: A Better Way to Assure Access to a Very Promising and Very Expensive Treatment CMS has determined that Medicare will cover CAR-T therapy when such therapy is provided in the context of a clinical study or trial that CMS has approved. For CMS, this is a rare National Coverage Determination (NCD) in cancer care. The policy balances the opportunity and need to make available to patients a very promising new treatment and, at the same time, satisfy the need to collect, analyze and report out on data and evidence that relates to what surely will be an expanding list of tumor type indications and an expanding list of provider-setting types. Many have likened the introduction of CAR-T therapy to the era of the introduction of high dose chemotherapy with bone marrow or stem cell transplantation. A difference in the CAR-T case is that the FDA has approved CAR-T products based upon some data submission. Further the price tags for CAR-T and HDCT-ABMT/SCT are both very expensive and the eventual total costs of CAR-T will only increase as such costs will include management of very serious side effects in some patients. Years ago in the early 1990s, I faced the HDCT/ABMT/SCT issue at Aetna. In an invited editorial in the Journal of the National Cancer Institute (McGivney, May, 1992), I proposed the initial thinking around the importance and need for ongoing data collection (Coverage with Evidence Development) to define the therapeutic indices for the various tumor types that HDCT ABMT/SCT would be used for. In return at introduction of a treatment, coverage would be provided at 60-70 centers nationwide to assure widespread access. Without going into great detail, the application of CED to CAR-T will help us avoid the concerns, consternation and conflicts that enveloped the HDCT/ABMT/SCT technology. CED should be applied sparingly but every great once in a while, a very promising, very expensive technology or treatment becomes available that needs to be made available to patients in need but that also needs to have an evidence-based definition of its therapeutic index to evaluate the benefit to be derived by future patients, including those patients with expanded indications. As such, the present Medicare NCD provides access through Medicare coverage as financial support and supports use and access in a very judicious manner for this critically important therapeutic approach. quotes

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FDA Alerts More Doctors Of Rare Cancer With Breast Implants

(Fox News/Associated Press) Feb 7, 2019 - U.S. health officials say doctors should be on the lookout for a rare cancer linked to breast implants after receiving more reports of the disease.

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William McGivney, PhD (Posted: February 11, 2019)

quotesBreast Implants; Déjà Vu All Over Again Last week’s FDA warning regarding the association of breast implants with the occurrence (infrequent) of anaplastic large cell lymphoma (BIA-ALCL) focuses attention yet again on the implications of implanting a foreign object within the human body and the potential for immune system reaction to that object. This latest FDA warning reminds one of the issues raised during the early- to mid-1990s regarding an association of breast implants with the occurrence of autoimmune disease. The latest FDA warning raises a compelling issue for payers: “will payers cover the explanting of breast implants based upon a beneficiary’s concern about possible occurrence of ALCL?”. For payers, the issue revolves around conservative coverage policy regarding preventative services. Generally, private payers reimburse only for preventative services (e.g., mammography, colonoscopy) that are recommended in recognized national guidelines. If a payer views the explantation of breast implants as a preventative service it will likely deny the surgical intervention to remove the breast implant. If there is an actual medical condition (e.g., inflammation due to saline or silicone leakage), a payer may then view the surgical intervention as treatment and provide coverage. The other issue that arises above straight liability issues is: should manufacturers of breast implants be required to pay for the explantation of their breast implants. Twenty-five years ago, when the autoimmune issue arose, there were extensive business/financial conflicts within the major payers (e.g., Aetna, CIGNA) between the interests of the property casualty business within such companies and the health insurance side of the major insurance company. The property casualty components insured many of the breast implant manufacturers and thus were loath to the idea that their health insurer component might force manufacturers to pay. In essence, it would have been property and casualty side paying on behalf of the insured, the manufacturer. It is likely that this FDA warning will not receive the prolonged, highly visible attention given the breast implant-autoimmune disease association but many of the same coverage issues will resurface within the health insurers. quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
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Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...